Potential Role of Intravenous Lidocaine Versus Intravenous Ketamine for Pain Management in Fibromyalgia Patients

NCT06184958 | Unknown Phase 4 DMC

• 1 other identifier: FMASUR332/2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous ketamine in treatment of fibromyalgia patients.

Conditions

Anesthesia

Keywords

Fibromyalgia,Ketamine, Lidocaine

Outcome Measures

Primary Outcomes (1)

• : Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS).

  Questionnaire to assess degree of pain relieve and improvement of physical activity, a scale from 0-10 where 0 is no pain or limitation and 10 is the worst unbearable pain perception. Asucess is achieved when decline in the scale takes place 3 points out of 10 , where at least reach 5

  Assessment will be done weekly for 3 weeks. First assessment will be 1week after first procedure ,on the same day of 2nd injection. 2nd assessment will be on the same day of the 3rd injection . 3rd assessment will be done 1 week after third injection

Secondary Outcomes (1)

• : Quality of life questionnaire that measures the patients' physical and psychological well-being.

  Pre-procedure measurement and another measurement will be assessed one month after first procedure

Study Arms (3)

Group A:Lidocaine group

ACTIVE COMPARATOR

5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks

Drug: Lidocaine group

Group B:Ketamine group

ACTIVE COMPARATOR

0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.

Drug: Ketamine group

Group C:Placebo group

PLACEBO COMPARATOR

Placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.

Drug: Placebo group

Interventions

Lidocaine group DRUG

Group A: Lidocaine group( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.

Group A:Lidocaine group

Ketamine group DRUG

Group B:Ketamine group(25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.

Group B:Ketamine group

Placebo group DRUG

Group C:placebo group (25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks

Group C:Placebo group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with FM, diagnosed according to the American College of Rheumatology (ACR) 2016 diagnostic criteria for FM. (Wolfe, F., Clauw, D. J., Fitzcharles, M. A., et al., 2016)

You may not qualify if:

• \- Known hypersensitivity to any of the given drugs or one of their derivatives (lidocaine or ketamine).
• Known Arrhythmia (Supraventricular or ventricular).
• Pregnant females.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

maha sadek El Derh

Cairo, 11721, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 29, 2023
• Study Start: September 2, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

EG (1)